Dietary Intervention With Brain-friendly Diet

NCT03346486 | Completed

• 1 other identifier: MFBF008 BRAVE
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of dietary intervention on metabolic risk profile, and on potential simultaneous changes in physiological and cognitive functions and to collect a unique database using state-of-the-art technologies on variables related to the above mentioned areas.

Conditions

Physiological Stress; Cognitive Performance; LDL Cholesterol

Keywords

Diet; Metabolites; Cognitive function; Physiology; LDL; Diet Habit; Diet Modification

Outcome Measures

Primary Outcomes (1)

• Change in LDL cholesterol

  Change in serum LDL concentration between control period and intervention period

  8 weeks

Secondary Outcomes (8)

• Change in serum metabolite concentrations

  8 weeks

• Change in cognitive performance

  4 weeks

• Changes in self-reported vigilance

  4 weeks

• Changes in self-reported task load

  4 weeks

• Daily pulse profile (evening- night- morning)

  8 weeks

Study Arms (2)

Control diet

PLACEBO COMPARATOR

Regular diet

Other: Control diet

Intervention diet

ACTIVE COMPARATOR

Brainfood diet

Other: Intervention diet

Interventions

Control diet OTHER

Regular diet

Control diet

Intervention diet OTHER

Brainfood dietary regime planned to be optimal for metabolism and cognitive function; having focus on regular meal frequency (breakfast, lunch and afternoon snack) and well-balanced light lunch at work according to the so-called plate model and optimized recipes- will be provided.

Also known as: Brainfood diet

Intervention diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Age 18-65 years
• Assumed metabolic risk based on pre-screening assessment of glucose and lipid metabolism related metabolites defined initially as being within the most impaired quartile with reference to available metabolite data-base from a comparable population. If recruitment efficiency requires, having a metabolic profile within the most impaired half instead of a quartile may be applied.
• Male or female with at least 1/3 of the gender defined predominant among screened participants with assumed metabolic risk
• Adequate Finnish or English skill to comprehend trial related instructions and questionnaires
• Chest circumference of 75 to 115 cm (limits included)

You may not qualify if:

• High probability to travel for more than one working day a week during the trial
• Expected or planned major changes in lifestyle (diet, level of exercise, significant changes in work) or involved in the R\&D of the measuring devices applied in the trial
• Allergies restricting compliance with control or intervention diet (celiac disease, gluten free diet, stringent FODMAP diet)
• Nickel allergy
• History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), temporal ischemic attack within the previous 6 months
• Diagnosed type 1 or type 2 diabetes requiring treatment
• Inflammatory bowel disease or other intestinal or oesophageal disease requiring medical treatment or likely to have a nutritional affect
• History of malignant diseases like cancer within five years prior to recruitment
• Lipid lowering medication (statin, cholestyramine) or medication for obesity (orlistat, or liraglutide) or depression
• Alcohol abuse (\> 4 portion/per day) or recreational drug abuse
• Pregnancy or planned pregnancy or lactating
• Suspected low compliance according to the investigator's assessment

Sponsors & Collaborators

• Fazer Group: lead
• Nokia Technologies Oy: collaborator
• Nightingale Health Oy: collaborator
• Tekes - the Finnish Funding Agency for Innovation: collaborator
• Finnish Institute of Occupational Health (FIOH): collaborator
• Oy Medfiles Ltd: collaborator

Study Sites (1)

Medfiles BRAVE clinic

Espoo, Finland

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Arja Uusitalo, MD

  FIOH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open, fixed sequence diet-switch 4-week intervention

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: November 17, 2017
• Study Start: August 24, 2017
• Primary Completion: April 3, 2018
• Study Completion: April 3, 2018
• Last Updated: June 20, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)